Another 8 million birth control pills are involved in a new recall implemented over a packaging error, the U.S. Food and Drug Administration (FDA) just announced.
Glenmark Generics Inc. is recalling seven lots of Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.035 mg, 0.215 mg/0.035 mg, and 0.25 mg/0.035 mg. Select blisters were rotated 180 degrees within the card, reversing the weekly tablet orientation and rendering the lot number and expiry date visible only on the outer pouch. Any blister for which the lot number and expiry date is not visible is subject to recall.
Norgestimate and Ethinyl Estradiol tablets are used as an oral contraceptive indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. This packaging error could render the daily regimen for these oral contraceptives incorrect, leaving women with inadequate contraception, and at risk for unintended pregnancy. Although the defects do not pose immediate health risks, consumers exposed to affected packaging should use nonhormonal contraception immediately. Patients in possession of the recalled Norgestimate and Ethinyl Estradiol tablets should notify their physician and return the product to the pharmacy of purchase.
The recalled Norgestimate and Ethinyl Estradiol tablets were manufactured and packaged by Glenmark Generics Ltd. India. and distributed by Glenmark Generics Inc. USA. This recalled tablets were distributed to wholesalers and retail pharmacies, nationwide, between September 21, 2011 and December 30, 2011 and distributed by Glenmark Generics Inc. only in the USA. The NDC is 68462-565-29 and involved lots 04110101, 04110106, 04110102 with expiration 07/31/2013; lots 04110114, 04110124, 04110129 with expiration 08/31/2013; and lot 04110134 with expiration 09/30/2013.
The problem was discovered when Glenmark received a consumer complaint that she received one blister pack in which the tablets were packaged in reverse order. The correct packaging configuration is of three pouch packs packaged per carton; each has one blister which contains 28 tablets.
Some pills were placed in the wrong order within the packs, explained FoxNews. Each pack contains three types of pills with different hormone levels. The pills are meant to be taken at different times during a woman’s cycle, said FoxNews. The sequence is white to off-white tablets on the top row and inactive light green tablets in bottom row. Each white to off white tablet contains 0.18 mg of the progestational compound, norgestimate USP, with 0.035 mg of the estrogenic compound, ethinyl estradiol USP. Each light blue tablet contains 0.215 mg of norgestimate USP, with 0.035 mg of ethinyl estradiol USP. Each blue tablet contains 0.25 mg of norgestimate USP, with 0.035 mg of ethinyl estradiol USP. Each light green tablet contains inert ingredients only.
Glenmark Generics Inc., USA can be reached, toll-free, at 1.888.721.7115 from 8:00 a.m. to 5:00 p.m., Monday through Friday, Eastern Standard Time (EST).
We recently wrote that Pfizer recalled 1 million birth control pill packages and could be facing lawsuits. A packaging problem was also to blame in that case. According to experts familiar with the matter, women who become pregnant after taking the defective birth control pills could sue Pfizer for their unwanted pregnancies, and could sue big.
A total of 14 lots each of Lo/Ovral-28 tablets and generic Norgestrel and Ethinyl Estradiol tablets were involved; both manufactured by Pfizer and marketed in the U.S. by Akrimax Rx Products under the Akrimax Pharmaceuticals brand. The recall followed Pfizer’s discovery that some packets contained too many, and others too few, of the active tablets. The packages should contain 21 active and 7 inactive sugar pills that, when taken correctly, regulate menstruation and provide contraception.
Pfizer said the issue was the result of mechanical and visual inspection failures that occurred on the packaging line, a problem Pfizer says has since been corrected. The recalled packages bear expiration dates from July 31, 2013 through March 31, 2014 and were distributed to warehouses, clinics, and retail pharmacies in the United States. The products are packaged in blister packs.